Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of SOF-SKN in Healthy Participants

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-64
SponsorNoxopharm Limited

About this trial

The goal of this study is to investigate the safety and tolerability of the topical application of SOF-SKN in healthy volunteers. The study will be divided into part 1 and part 2.

Part 1, is a single ascending dose (SAD) design, while Part 2 is a multiple ascending dose (MAD) design.

Eligibility criteria

Qualifiers

Healthy Volunteers 18 to 64 years.

Participants with Fitzpatrick skin type I to IV.

Participants must have a back surface area of at least 24 × 30 cm to accommodate two - 10 × 30 cm application areas with a 4 cm separation between them.

No Allergies.

Disqualifiers

Allergic constitution.

Within 72 hours of the start of study treatment, the use of antihistamines or use of topical drugs at the application site.

Hair removing interventions including laser treatment, shaving and waxing in the target area within 1 week before Screening.

Hypertrichosis on the back; no tattoos that cover greater than 30% of the back surface area.

Trial design

Treatments tested in this trial

  • SOF-SKN 0.25%
  • SOF-SKN 0.5%
  • SOF-SKN 1%
  • SOF-SKN 2%
  • Placebo

Treatment groups

32 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Sponsors and collaborators